Active not recruitingOBSERVATIONAL

Validation and Standardization of Paramagnetic Rim Lesion (PRL) Identification in Multiple Sclerosis Across MAGNIMS Centers

This study is about making sure that certain features on brain scans of people with Multiple Sclerosis (MS) are identified in the same way by different doctors and at different hospitals. These features, called 'paramagnetic rim lesions' (PRLs), are important because they can show if MS is more active. For PRLs to be useful in guiding treatment or in future research, doctors need to be consistent in spotting them. The researchers are looking at already-taken MRI scans from MS patients across 15 different medical centres. They are checking how well experts agree on identifying PRLs. If there are differences, they will refine the guidelines for spotting them and then re-test. This study uses only existing, anonymised scans and patient information; no new patients are involved, and no new scans are taken.

At a glance

Status

Active not recruiting

Sponsor

IRCCS San Raffaele

Enrolment target

1,402

Start

01 Jan 2017

Estimated completion

01 Dec 2028

Multiple Sclerosis

What is this study about?

This study is looking into how we can get a clearer and more consistent picture of Multiple Sclerosis (MS) using special brain scans called MRIs. For people with MS, tiny spots or 'lesions' can appear on their brain scans. Some of these are called 'paramagnetic rim lesions' (PRLs), and they're particularly important because they can suggest that a person's MS might be more active or aggressive. Doctors are starting to use these PRLs, along with other signs, to help diagnose and understand MS better.

However, for PRLs to be truly helpful across all hospitals and in new research studies, everyone needs to be able to identify them in the same way. Imagine different chefs trying to follow a recipe, but each one has a slightly different idea of what an 'egg' looks like! This study aims to make sure all experts agree on what a PRL looks like on a scan. They are taking a library of existing brain scans from MS patients across many different hospitals and asking expert doctors to identify the PRLs. They'll then check how much agreement there is between these experts and across the different hospitals.

If the experts don't always agree, the study will help figure out why. They will then try to make the guidance for identifying PRLs even clearer and test it again. The main goal is to create a standard, reliable way for all doctors to spot these important lesions. This will help make future MS diagnoses more accurate and ensure that research studies using these lesions are more dependable, ultimately leading to better care for people with MS.

Key takeaways

This study uses existing MRI scans from MS patients, not new participants.
It aims to make sure doctors identify specific brain lesions (PRLs) consistently across different hospitals.
PRLs are important because they can show how active Multiple Sclerosis is.
Better consistency helps with future MS diagnosis and research into treatments.
No personal identifiable information is used; all data is anonymous.
The study focuses on improving standards, not on direct patient treatment.

Who may be eligible?

This study isn't actually looking for new patients to take part. Instead, it's using information that has already been collected from previous patients and their MRI scans. So, you don't need to do anything to be 'eligible' for this study yourself.

The existing MRI scans and patient information used in this project come from people who:

* Were already diagnosed with Multiple Sclerosis (MS) using the standard criteria (called the 2017 McDonald Criteria). * Were 18 years old or older when they had their MRI scan. * Had specific types of 3T MRI brain scans that met certain quality and detail requirements, including scans taken before and after a special dye (gadolinium). * Crucially, these patients must have previously given their permission for their scan information and medical details to be used for research purposes.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You already have a confirmed diagnosis of Multiple Sclerosis (MS).
You were 18 years old or older when you had your MRI scan.
You previously had specific types of high-quality 3T MRI brain scans.
You previously gave permission for your anonymised scan and medical data to be used for research.

Answer every question to see your result.

What does participation involve?

You won't be directly involved in this study. This research uses information from MRI scans and medical records that have already been collected from other patients in the past. No new appointments, tests, medications, or follow-up visits are needed from you. The study simply analyses existing data to help improve how doctors understand and treat MS in the future.

Potential risks and benefits

Since this study only uses existing, anonymised information and scans, there are no direct risks or benefits to individual patients. The information collected is already de-identified, meaning your personal details are removed so no one can link the scans back to you. The wider benefit is that the study aims to improve how doctors consistently spot important features on MS brain scans. This could lead to more accurate diagnoses and better-focused research into MS treatments in the future. As no new patients are involved, there is no right to withdraw from this data-only study.

Locations (15)

Medical University Graz
Verified postcode
Graz, Austria
Medical University of Vienna
Verified postcode
Vienna, Austria
Charles University and General University Hospital
Verified postcode
Prague, Czechia
Danish Research Centre for Magnetic Resonance
Verified postcode
Copenhagen, Denmark
University Medical Center Mainz
Verified postcode
Homburg, Germany
IRCCS San Raffaele
Verified postcode
Milan, Italy
University Hospital of Padua
Verified postcode
Padova, Italy
University of Verona
Verified postcode
Verona, Italy
Amsterdam UMC
Verified postcode
Amsterdam, Netherlands
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Verified postcode
Oslo, Norway
Vall d'Hebron University Hospital
Verified postcode
Barcelona, Spain
Karolinska Neuroimmunology & Multiple Sclerosis (KNIMS) Centre
Verified postcode
Stockholm, Sweden

Common questions

Am I being asked to take part in this study?

No, this study is only using existing information from previous MRI scans and medical records. You are not being asked to participate.

What are 'paramagnetic rim lesions' (PRLs)?

PRLs are specific small spots seen on special MRI brain scans of people with MS, which can show that the MS is more active. This study aims to help doctors identify them consistently.

Why is it important for doctors to agree on identifying these lesions?

Consistent identification means doctors can better understand how active MS is, which helps with diagnosis and planning future research and treatments more reliably.

Will my personal medical information be used?

No, the study only uses 'de-identified' information, meaning all personal details have been removed so that no one can connect the information back to you.

Will this study find a cure for MS?

This study won't find a cure, but by improving how we understand and identify MS features on scans, it lays important groundwork for future research that could lead to better treatments.